Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery

Postoperative Pain Clinical Trial

Official title:

Pharmacokinetics of Morphine and Oxycodone in Frail Elderly Undergoing Cardiac Surgery - AGE AWARE II

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04696445
• Other study ID #: NL71713.100.20
• Secondary ID: 2020-001462-10
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: November 26, 2021

Study information

• Verified date: June 2022
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• Single centre observational cohort study.

• 20 older patients undergoing cardiac surgery who receive standard of care pain treatment.

• Postoperative ICU: blood sampling to determine morphine and metabolite (M3G, M6G, noroxycodone and oxymorphone) pharmacokinetics

• After ICU discharge on general ward: blood sampling to determine morphine, oxycodone and metabolite (M3G, M6G, noroxycodone and oxymorphone) pharmacokinetics

• During study monitoring of pain scores, total opioid consumption, side effects (e.g. nausea, vomiting, pruritus), sedation and delirium scores.

Description:

Postoperative pain after cardiac surgery in elderly patients is common and leads to postoperative complications. Opioids play an important role in treatment of postoperative pain after cardiac surgery. In frail elderly after cardiac surgery however dosing schemes for opioids are still unknown, potentially leading to inadequate treatment of pain and/or safety issues.

• Single center observational cohort study

• The study population includes frail patients ≥70 years undergoing elective cardiac surgery.

• Primary endpoints of this study is the concentration of morphine, oxycodone and metabolites in blood over time on behalf of pharmacokinetic modelling.

• Secondary endpoints of this study are the pharmacodynamic parameters of morphine, oxycodone and metabolites (M3G, M6G, noroxycodone and oxymorphone) in blood in frail patients; such as pain scores, postoperative opioid consumption, vital signs, side effects of opioids and the influence of covariates such as frailty, serum creatinine, Glomerular Filtration Rate (GFR) on the pharmacokinetics and pharmacodynamics of morphine and oxycodone.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 34
• Est. completion date: November 26, 2021
• Est. primary completion date: November 26, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 70 Years and older

Eligibility

Inclusion Criteria:

• =70 years undergoing elective cardiac surgery.

Exclusion Criteria:

• Patients undergoing transcatheter aortic valve replacement or mitral valve repair

• Contra-indication for morphine and/or oxycodone

Related Conditions & MeSH terms

• Drug-Related Side Effects and Adverse Reactions
• Opioid Use
• Postoperative Pain
• Side Effect of Drug

Intervention

Drug:
• Morphine & Oxycodone
Morphine and Oxycodone are used in daily practice as part of standard care. Morphine and Oxycodone will be acquired through the clinical pharmacy of St Antonius and administered according to the standard postoperative pain protocol.

Locations

Country	Name	City	State
Netherlands	St Antonius hospital	Nieuwegein

Sponsors (2)

Lead Sponsor	Collaborator
St. Antonius Hospital	Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	M3G concentration in blood over time	Analysis of serum concentrations of M3G, metabolite of morphine, for pharmacokinetic modelling	Until three consecutive days after ICU discharge
Primary	M6G concentration in blood over time	Analysis of serum concentrations of M6G, metabolite of morphine, for pharmacokinetic modelling	Until three consecutive days after ICU discharge
Primary	Noroxycodone concentration in blood over time	Analysis of serum concentrations of Noroxycodone, metabolite of oxycodone, for pharmacokinetic modelling	Until three consecutive days after ICU discharge
Primary	Oxymorphone concentration in blood over time	Analysis of serum concentrations of Oxymorphone, metabolite of oxycodone, for pharmacokinetic modelling	Until three consecutive days after ICU discharge
Secondary	Numeric Rating Scale (NRS; 0-10, 0 = none, 10 = severe)	NRS as pain measurement scale, reported by nurse in standard care, for pharmacodynamic modelling	Until three consecutive days after ICU discharge
Secondary	Postoperative opioid consumption	Postoperative opioid consumption, mg per 24 hour, for pharmacodynamic modelling	Until three consecutive days after ICU discharge
Secondary	Side effects of opioids	Side effects of opioids (pruritis, vomiting, constipation, nausea), dichotomous (yes/no) each day by nurse/researcher, for pharmacodynamic modelling	Until three consecutive days after ICU discharge
Secondary	Vital sign observation: bloodpressure (in mmHg) by nurse	Systolic and diastolic bloodpressure (SBP, DBP), reported by nurse in standard care for pharmacodynamic modelling	Until three consecutive days after ICU discharge
Secondary	Vital sign observation: heartrate (in beats/minute) by nurse	Heartrate (HR) reported by nurse in standard care for pharmacodynamic modelling	Until three consecutive days after ICU discharge
Secondary	Vital sign observation: saturation (in %) by nurse	Saturation (SpO2), reported by nurse in standard care for pharmacodynamic modelling	Until three consecutive days after ICU discharge